National Diet and Nutrition Survey

NHS Central Register and Cancer Register

(Adults 16+)

- The NHS Central Register lists all the people in the country and their National Health Service (NHS) number.
- We would like to ask for your consent for us to send your name, address and date of birth to the National Health Service Central Register. A marker will be put against your name to show that you took part in the National Diet and Nutrition Survey.
- If a person who took part in the National Diet and Nutrition Survey (NDNS) gets cancer, or dies, the type of cancer or cause of death will be linked with their answers to the survey. By linking this information the research is more useful as we can look at how people’s lifestyle can have an impact on their future health.
- This information will be confidential and used for research purposes only.
- By signing this form you are only giving permission for the linking of this information to routine administrative data and nothing else. We will not be able to obtain any other details from your medical records.
- You can cancel this permission at any time in the future by writing to us at the following address: NatCen Social Research, 35 Northampton Square, London EC1V 0AX

Your consent

I, (name) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ consent to the NDNS team passing my name, address and date of birth to the National Health Service Central Register. I understand that information held by the NHS Central Register may be used to follow up my health status.

Signed \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

I understand that these details will be used for research purposes only. NDNS(N)

National Diet and Nutrition Survey (NDNS)

CONSENT BOOKLET: PERSONAL COPY

Serial Number:

First Name:

Annex 49_Nurse visit consent booklet_personal_v8 National Diet and Nutrition Survey (NDNS) Nurse Visit ADULT CONSENT FORM (16+ years)

MREC Reference Number: 13/EE/0016

Please use capital letters and write in ink

SERIAL NUMBER

CHECK LETTER

RESPONDENT No.

Please initial/tick boxes if consent given

1. I confirm that I have read and understand the NDNS Nurse Visit information sheet(s) dated 05.02.2014 (version 2) for the above study. I have been given the opportunity to ask questions and have had these answered satisfactorily.

2. I understand that my participation is voluntary and that I am free to withdraw from any part of the study, at any time, without giving a reason and without my medical care or legal rights being affected.

MEASUREMENTS

3. I agree for my blood pressure results to be sent to my GP.

4. I agree for my body mass index (BMI) measurement to be sent to my GP.

Name of participant (please print) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date \_\_\_\_\_\_\_\_\_\_ Signature \_\_\_\_\_\_\_\_\_\_

Name of nurse (please print) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date \_\_\_\_\_\_\_\_\_\_ Signature \_\_\_\_\_\_\_\_\_\_ National Diet and Nutrition Survey (NDNS) Nurse Visit ADULT CONSENT FORM (16+ years)

MREC Reference Number: 13/EE/0016 Please use capital letters and write in ink

SERIAL NUMBER

CHECK LETTER

RESPONDENT No.

Please initial/tick boxes if consent given

BLOOD SAMPLE

5. I agree to have a blood sample taken as part of the study.

6. I give permission that my blood sample taken as part of this study may be stored and, with ethical approval as appropriate, used in future research studies.

7. I would like to receive my blood results which are clinically relevant.

8. I consent to my GP being notified of my blood results which are clinically relevant.

9. You will be required to consent to the statement below if you do not want to receive your blood results AND if you do not want them sent to your GP. I confirm that against the advice of the NDNS survey team, I do not want to receive my blood results which are clinically relevant or have them sent to my GP. I understand that if there are findings outside of the normal range, this will not be brought to the attention of any health care provider.

Name of participant (please print) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date \_\_\_\_\_\_\_\_\_\_\_ Signature \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Name of nurse (please print) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date \_\_\_\_\_\_\_\_\_\_\_ Signature \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ National Diet and Nutrition Survey (NDNS) Nurse Visit PARENTAL/GUARDIAN CONSENT FOR CHILD (4-15 YEARS)

MREC Reference Number: 13/EE/0016

Please use capital letters and write in ink

SERIAL NUMBER

CHECK LETTER

RESPONDENT No.

Name of Child \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

1. I am the parent/guardian of the child named above and I confirm that I have read and understand the NDNS Nurse Visit information sheet(s) dated 05.02.2014 (version 2) for the above study. I have been given the opportunity to ask questions and have had these answered satisfactorily.

2. I understand that my child’s participation is voluntary and that s/he is free to withdraw from any part of the study, at any time, without giving a reason and without my medical care or legal rights being affected.

MEASUREMENTS

3. I agree for my child’s blood pressure results to be sent to his/her GP.

Name of Parent/Guardian (please print) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date \_\_\_\_\_\_\_\_\_\_ Signature \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Name of nurse (please print) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date \_\_\_\_\_\_\_\_\_\_ Signature \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ National Diet and Nutrition Survey (NDNS) Nurse Visit PARENTAL/GUARDIAN CONSENT FOR CHILD (4-15 YEARS)

MREC Reference Number: 13/EE/0016 Please use capital letters and write in ink

| SERIAL NUMBER | CHECK LETTER | RESPONDENT No. | |---------------|--------------|----------------| | | | |

Name of Child \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

BLOOD SAMPLE

4. I agree to my child having a blood sample taken as part of the study.

5. I give permission that my child’s blood sample taken as part of this study may be stored and, with ethical approval as appropriate, used in future research studies.

6. I would like to receive my child’s blood results which are clinically relevant.

7. I consent to my child’s GP being notified of his/her blood results which are clinically relevant.

8. IF you do not want to receive your child’s blood results AND if you do not want them sent to their GP, for us to take a blood sample from your child, you will be required to consent to both of the statements below.

   (i) I confirm that against the advice of the NDNS survey team, I do not want to receive my child’s blood results which are clinically relevant or have them sent to his/her GP.

   (ii) I agree to the survey doctor contacting me to discuss, if necessary, any results that are directly relevant to my child’s health.

Name of Parent/Guardian (please print) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date \_\_\_\_\_\_\_\_\_\_ Signature \_\_\_\_\_\_\_\_\_\_

Name of nurse (please print) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date \_\_\_\_\_\_\_\_\_\_ Signature \_\_\_\_\_\_\_\_\_\_ National Diet and Nutrition Survey (NDNS) Nurse Visit

CHILD ASSENT FORM (5-15 years)

MREC Reference Number: 13/EE/0016

Please use capital letters and write in ink

| SERIAL NUMBER | CHECK LETTER | RESPONDENT No. | |---------------|--------------|----------------| | | | |

Please circle

1. Has somebody explained what happens at the nurse visit? Yes / No
2. Do you understand what this study is about? Yes / No
3. Have you asked all the questions you want? Yes / No
4. Have you had your questions answered in a way you understand? Yes / No
5. Do you understand it's OK to stop taking part at any time? Yes / No
6. Are you happy to take part? Yes / No

If any answers are 'No' or you don't want to take part, don't sign your name!

If you do want to take part, you can write your name below.

Your name

______________________________________________________________________

Date

The nurse who explained this study to you needs to sign too:

Nurse name

______________________________________________________________________

Signature

______________________________________________________________________

Date

______________________________________________________________________

Thank you for helping us! National Diet and Nutrition Survey (NDNS) Nurse Visit PARENTAL/GUARDIAN CONSENT FOR CHILD (1.5-3 YEARS)

MREC Reference Number: 13/EE/0016

Please use capital letters and write in ink

| SERIAL NUMBER | CHECK LETTER | RESPONDENT No. | |---------------|--------------|----------------| | | | |

Name of Child \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

1. I am the parent/guardian of the child named above and I confirm that I have read and understand the NDNS Nurse Visit information sheet(s) dated 05.02.2014 (version 2) for the above study. I have been given the opportunity to ask questions and have had these answered satisfactorily.

2. I understand that my child’s participation is voluntary and that s/he is free to withdraw from any part of the study, at any time, without giving a reason and without our medical care or legal rights being affected.

Name of Parent/Guardian (please print) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date \_\_\_\_\_\_\_\_\_\_\_\_ Signature \_\_\_\_\_\_\_\_\_\_\_\_

Name of nurse (please print) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date \_\_\_\_\_\_\_\_\_\_\_\_ Signature \_\_\_\_\_\_\_\_\_\_\_\_

BLOOD SAMPLE

3. I agree to my child having a blood sample taken as part of the study.

4. I give permission that my child’s blood sample taken as part of this study may be stored and, with ethical approval as appropriate, used in future research studies.

5. I would like to receive my child’s blood results which are clinically relevant.

6. I consent to my child’s GP being notified of his/her blood results which are clinically relevant.

7. **IF you do not want to receive your child’s blood results AND if you do not want them sent to their GP, for us to take a blood sample from your child, you will be required to consent to both of the statements below.**

   (i) I confirm that against the advice of the NDNS survey team, I do not want to receive my child’s blood results which are clinically relevant or have them sent to his/her GP.

   (ii) I agree to the survey doctor contacting me to discuss, if necessary, any results that are directly relevant to my child’s health.

Name of Parent/Guardian (please print) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date \_\_\_\_\_\_\_\_\_\_\_\_ Signature \_\_\_\_\_\_\_\_\_\_\_\_

Name of nurse (please print) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date \_\_\_\_\_\_\_\_\_\_\_\_ Signature \_\_\_\_\_\_\_\_\_\_\_\_ National Diet and Nutrition Survey – Consent Booklet: Office Copy

Please use capital letters and write in ink

ADDRESS

INDIVIDUAL SERIAL NUMBER: Affix label NCON here for this person:

STICK NCON (1) LABEL HERE

1. Nurse number: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

2. Date schedule completed (all visits complete): DAY: \_\_\_\_\_\_\_ MONTH: \_\_\_\_\_\_\_ YEAR: \_\_\_\_\_\_\_

3. Full name (of person tested) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

   Name by which GP knows person (if different) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

4. Sex Male 1 Female 2

5. Date of birth: DAY: \_\_\_\_\_\_\_ MONTH: \_\_\_\_\_\_\_ YEAR: \_\_\_\_\_\_\_

6. Full name of parent/guardian (if person under 16) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

7. GP NAME AND ADDRESS Dr: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Practice Name: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Address: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

   ______________________________________________________________________

   ______________________________________________________________________

   Town: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ County: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Postcode: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Telephone no: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

   NURSE USE ONLY GP Address complete 1 GP Address not complete 2 No GP 3

8. SUMMARY OF CONSENTS—RING CODE FOR EACH ITEM a) Read and understood nurse visit information sheet YES 01 NO 02 b) Understand right to withdraw YES 03 NO 04 c) Blood pressure to GP YES 05 NO 06 d) Body Mass Index (BMI) to GP YES 07 NO 08 e) Sample of blood to be taken YES 09 NO 10 f) Blood sample for storage YES 11 NO 12 g) Blood sample result to participant YES 13 NO 14 h) Blood sample result to GP YES 15 NO 16 i) Does not wish to receive results or have them sent to GP YES 17 NO 18 j) Agrees survey doctor can contact to discuss results if necessary – YES 19 NO 20 Children aged 1.5-15 years

# BLOOD SAMPLE LABORATORY REFERENCE LIST

The tables below show which blood samples should be taken (in priority order) and need to be sent to each lab for each age group:

## PARTICIPANTS AGED 16+

| Priority | Blood Tube | Colour | Label Reference | Laboratory | |----------|--------------|--------|-----------------|--------------| | 1 | EDTA 2.6 mL | Red | EN1 (3) | Addenbrookes | | 2 | Serum 9.0 mL | White | SEN 1 (4) | Field Lab | | 3 | Li Hep TM 7.5 mL | Orange | LHN1 (5) | Field Lab | | 4 | Li Hep TM 7.5 mL | Orange | LHN2 (6) | Field Lab | | 5 | Fluoride 1.2 mL | Yellow | FN1 (7) | Field Lab | | 6 | Li Hep 4.5 mL | Orange | LHN3 (8) | Field Lab | | 7 | EDTA 2.6 mL | Red | EN2 (9) | Field Lab |

## PARTICIPANTS AGED 7-15

| Priority | Blood Tube | Colour | Label Reference | Laboratory | |----------|--------------|--------|-----------------|--------------| | 1 | EDTA 2.6 mL | Red | EN1 (3) | Addenbrookes | | 2 | Serum 7.5 mL | White | SEN1 (4) | Field Lab | | 3 | Li Hep TM 7.5 mL | Orange | LHN1 (5) | Field Lab | | 4 | Li Hep 2.7 mL | Orange | LHN2 (6) | Field Lab | | 5 | Fluoride 1.2 mL | Yellow | FN1 (7) | Field Lab |

## PARTICIPANTS AGED 18 mths – 6 yrs

| Priority | Blood Tube | Colour | Label Reference | Laboratory | |----------|--------------|--------|-----------------|--------------| | 1 | EDTA 2.6 mL | Red | EN1 (3) | Addenbrookes | | 2 | Serum 4.5 mL | White | SEN1 (4) | Field Lab | | 3 | Li Hep 4.5 mL | Orange | LHN1 (5) | Field Lab | National Diet and Nutrition Survey (NDNS) Nurse Visit ADULT CONSENT FORM (16+ years)

MREC Reference Number: 13/EE/0016

Please use capital letters and write in ink

| SERIAL NUMBER | CHECK LETTER | RESPONDENT No. | |---------------|--------------|----------------| | | | |

1. I confirm that I have read and understand the NDNS Nurse Visit information sheet(s) dated 05.02.2014 (version 2) for the above study. I have been given the opportunity to ask questions and have had these answered satisfactorily.

2. I understand that my participation is voluntary and that I am free to withdraw from any part of the study, at any time, without giving a reason and without my medical care or legal rights being affected.

MEASUREMENTS

3. I agree for my blood pressure results to be sent to my GP.

4. I agree for my body mass index (BMI) measurement to be sent to my GP.

Name of participant (please print) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date \_\_\_\_\_\_\_\_\_\_ Signature \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Name of nurse (please print) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date \_\_\_\_\_\_\_\_\_\_ Signature \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Please initial/tick boxes if consent given National Diet and Nutrition Survey (NDNS) Nurse Visit ADULT CONSENT FORM (16+ years)

MREC Reference Number: 13/EE/0016

Please use capital letters and write in ink

| SERIAL NUMBER | CHECK LETTER | RESPONDENT No. | |---------------|--------------|----------------| | | | |

BLOOD SAMPLE

5. I agree to have a blood sample taken as part of the study.

6. I give permission that my blood sample taken as part of this study may be stored and, with ethical approval as appropriate, used in future research studies.

7. I would like to receive my blood results which are clinically relevant.

8. I consent to my GP being notified of my blood results which are clinically relevant.

9. You will be required to consent to the statement below if you do not want to receive your blood results AND if you do not want them sent to your GP.

I confirm that against the advice of the NDNS survey team, I do not want to receive my blood results which are clinically relevant or have them sent to my GP. I understand that if there are findings outside of the normal range, this will not be brought to the attention of any health care provider.

Name of participant (please print) Date Signature

Name of nurse (please print) Date Signature National Diet and Nutrition Survey (NDNS) Nurse Visit PARENTAL/GUARDIAN CONSENT FOR CHILD (4-15 YEARS)

MREC Reference Number: 13/EE/0016

Please use capital letters and write in ink

| SERIAL NUMBER | CHECK LETTER | RESPONDENT No. | |---------------|--------------|----------------| | | | |

Name of Child \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

1. I am the parent/guardian of the child named above and I confirm that I have read and understand the NDNS Nurse Visit information sheet(s) dated 05.02.2014 (version 2) for the above study. I have been given the opportunity to ask questions and have had these answered satisfactorily.

2. I understand that my child’s participation is voluntary and that s/he is free to withdraw from any part of the study, at any time, without giving a reason and without my medical care or legal rights being affected.

MEASUREMENTS

3. I agree for my child's blood pressure results to be sent to his/her GP.

Name of Parent/Guardian (please print) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date \_\_\_\_\_\_\_\_\_\_ Signature \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Name of nurse (please print) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date \_\_\_\_\_\_\_\_\_\_ Signature \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ National Diet and Nutrition Survey (NDNS) Nurse Visit PARENTAL/GUARDIAN CONSENT FOR CHILD (4-15 YEARS)

MREC Reference Number: 13/EE/0016 Please use capital letters and write in ink

| SERIAL NUMBER | CHECK LETTER | RESPONDENT No. | |---------------|--------------|----------------| | | | |

Name of Child \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

BLOOD SAMPLE

4. I agree to my child having a blood sample taken as part of the study. [ ]

5. I give permission that my child’s blood sample taken as part of this study may be stored and, with ethical approval as appropriate, used in future research studies [ ]

6. I would like to receive my child’s blood results which are clinically relevant. [ ]

7. I consent to my child’s GP being notified of his/her blood results which are clinically relevant. [ ]

8. IF you do not want to receive your child’s blood results AND if you do not want them sent to their GP, for us to take a blood sample from your child, you will be required to consent to both of the statements below.

   (i) I confirm that against the advice of the NDNS survey team, I do not want to receive my child’s blood results which are clinically relevant or have them sent to his/her GP. [ ]

   (ii) I agree to the survey doctor contacting me to discuss, if necessary, any results that are directly relevant to my child’s health. [ ]

Name of Parent/Guardian (please print) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date \_\_\_\_\_\_\_\_\_\_ Signature \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Name of nurse (please print) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date \_\_\_\_\_\_\_\_\_\_ Signature \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ National Diet and Nutrition Survey (NDNS) Nurse Visit

CHILD ASSENT FORM (5-15 years)

MREC Reference Number: 13/EE/0016

Please use capital letters and write in ink

SERIAL NUMBER

CHECK LETTER

RESPONDENT No.

Please circle

1. Has somebody explained what happens at the nurse visit? Yes / No
2. Do you understand what this study is about? Yes / No
3. Have you asked all the questions you want? Yes / No
4. Have you had your questions answered in a way you understand? Yes / No
5. Do you understand it’s OK to stop taking part at any time? Yes / No
6. Are you happy to take part? Yes / No

If any answers are ‘No’ or you don’t want to take part, don’t sign your name!

If you do want to take part, you can write your name below.

Your name

______________________________________________________________________

Date

The nurse who explained this study to you needs to sign too:

Nurse name

______________________________________________________________________

Signature

______________________________________________________________________

Date

______________________________________________________________________

Thank you for helping us! National Diet and Nutrition Survey (NDNS) Nurse Visit

PARENTAL/GUARDIAN CONSENT FOR CHILD (1.5-3 YEARS)

MREC Reference Number: 13/EE/0016

Please use capital letters and write in ink

| SERIAL NUMBER | CHECK LETTER | RESPONDENT No. | |---------------|--------------|----------------|

Name of Child

1. I am the parent/guardian of the child named above and I confirm that I have read and understand the NDNS Nurse Visit information sheet(s) dated 05.02.2014 (version 2) for the above study. I have been given the opportunity to ask questions and have had these answered satisfactorily.

2. I understand that my child’s participation is voluntary and that s/he is free to withdraw from any part of the study, at any time, without giving a reason and without our medical care or legal rights being affected.

Name of Parent/Guardian (please print) Date Signature

Name of nurse (please print) Date Signature

BLOOD SAMPLE

3. I agree to my child having a blood sample taken as part of the study.

4. I give permission that my child’s blood sample taken as part of this study may be stored and, with ethical approval as appropriate, used in future research studies.

5. I would like to receive my child’s blood results which are clinically relevant.

6. I consent to my child’s GP being notified of his/her blood results which are clinically relevant.

7. **IF you do not want to receive your child’s blood results AND if you do not want them sent to their GP, for us to take a blood sample from your child, you will be required to consent to both of the statements below.**

   (i) I confirm that against the advice of the NDNS survey team, I do not want to receive my child’s blood results which are clinically relevant or have them sent to his/her GP.

   (ii) I agree to the survey doctor contacting me to discuss, if necessary, any results that are directly relevant to my child’s health.

Name of Parent/Guardian (please print) Date Signature

Name of nurse (please print) Date Signature **RESEARCH ANALYSIS REQUEST**

**Nurses - fill in YELLOW section only**

| Volunteer Details | Study Details | |-------------------|---------------| | **Surname:** HNR \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ (use 10 digit ID at top of label) | **Consultant** Dr Sumantra Ray | | **First name:** P952 | **Location** Project 952 | | **External ID:** EN1 \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ (use 7 digit no. at bottom of EN1 label) | **Title** NDNS | | **DOB** / / dd/mm/yyyy | **Contact** HNR Switchboard 01223 426356 Sonja Nicholson Karen Chamberlain Kate Guberg | | **Male** 1 circle as appropriate | **Contact OOH** Dr Sumantra Ray 0799 062 6671 | | **Female** 2 circle as appropriate | |

| Sample Details | | |----------------|----------------| | **Date** / / dd/mm/yyyy | **Volunteer Fasted** Yes 1 circle as appropriate | | **Time** : 24hr clock | **No** 2 circle as appropriate |

| Sample Tube | Tests | Lab order | Lab barcode | Lab processing | |-------------|-------|-----------|-------------|----------------| | EDTA EN1 red | Circle as appropriate | HbA1C - print 2 labels | LAB90 | ENDO BARCODE | | | Full tube | Folate Store - print 3 labels | LAB6108 Database search box will appear, click database lookup tab and select | BIOCHEM BARCODE | | | Partial tube | FBC - print 2 labels | LAB294 | HAEM BARCODE |

**EDTA separation**

Depending on sample volume split the whole blood in the following priority

**FBC**

Minimum volume required is 1ml – there will be three options:

- Volume less than 1ml (e.g. partial sample) proceed to folate aliquoting and cancel FBC adding comment: Insufficient sample for Haem in the cancellation comments and white box req comments field.
- Volume very close to 1ml send primary tube to Haem with the pink duplicate request form, cancel the HbA1C TEST adding the comment: Insufficient sample for HbA1c in the cancellation comments and white box req comments field.
- Volume more than ~1.5ml proceed to aliquoting whole blood for folate.

**Folate**

Take 2x 2ml tubes of ascorbic acid from the bottom half of the -80°C Protect freezer and defrost. Each contains 1ml ascorbic acid – check it has not expired. Label 2x defrosted 2ml ascorbic acid tubes with HNR barcode labels (FOL1 & FOL2) supplied in the delivery pack. Only label with patient biochem barcodes if there have been no HNR labels (FOL1 & FOL2) sent. Invert the primary EDTA tube a few times to re-suspend the contents Transfer exactly 100µl from primary EDTA tube into each tube containing 1ml ascorbic acid and invert to mix Store in the -80°C Protect freezer If there is sufficient volume proceed to aliquoting whole blood for HbA1C then primary tube to Haem with the pink duplicate request form If there is insufficient volume left for HbA1C, cancel adding the comment: Insufficient sample for HbA1C in the cancellation comments and white box req comments field.

**HbA1C**

Label 1x 2ml secondary tube with Endo HbA1C barcode Invert the primary EDTA tube a few times to re-suspend the contents Transfer 0.5ml from primary EDTA tube into secondary tube Place secondary tube in HbA1C skip in office National Diet and Nutrition Survey (NDNS) ADULT FIELD LAB DESPATCH NOTE – 16+ YEARS

Nurse Section

Participant details

Sex: Male / Female Fasted sample: Yes / No Sample collection date: DD / MM / YY Sample collection time: HH : MM 24 hr clock

Have you delivered all the items on the checklist to the field lab?

Time samples delivered to field lab: HH : MM 24 hr clock

Field Lab Section

Date sample arrived: DD / MM / YY Time sample arrived: HH : MM 24 hr clock

| Blood Monovette Tubes | SEN1 | LHN1 | LHN2 | LHN3 | FN1 | EN2 | |-----------------------|------|------|------|------|-----|-----| | Sample received? | Yes/No | Yes/No | Yes/No | Yes/No | Yes/No | Yes/No | | Is tube full or partial? | Full / Partial | Full / Partial | Full / Partial | Full / Partial | Full / Partial | Full / Partial | | Is tube damaged? | Yes/No | Yes/No | Yes/No | Yes/No | Yes/No | Yes/No |

Take 1300µl whole blood from well mixed LHN3 tube. Use 2ml microtube. Label with LHWB (15).

µl Volume aliquotted HH:MM Time aliquotted HH:MM Time in freezer

Centrifuge tubes for 20mins at 4°C and 2000g

Time tubes placed in the centrifuge HH:MM HH:MM HH:MM HH:MM HH:MM HH:MM

Did you use a refrigerated centrifuge? Yes / No

If NO, explain here what you did to keep samples cool:

Annex 50_Nurse visit consent booklet_office_v10\_ NDNS RP Y6-9 Describe here any problems or deviations from protocol:

| Blood Monovette Tubes | |------------------------| | SEN1 | LHN1 | LHN2 | LHN3 | FN1 | EN2 | | Is sample normal? | Yes/No | Yes/No | Yes/No | Yes/No | Yes/No | Yes/No |

If NO, describe e.g. haemolysed, cloudy, clotted, not clotted (SEN1 only)

| Microtube size | 5ml | 5ml | 5ml | 5ml | 2ml | 2ml | |----------------|-----|-----|-----|-----|-----|-----| | Attach label | SERUM | LIHEP1 | LIHEP2 | LIHEP3 | FLOX | EDTA | | Time aliquotted: | HH:MM | HH:MM | HH:MM | HH:MM | HH:MM | HH:MM |

Take EXACTLY 300µl plasma from LIHEP1. Use 2ml microtube with green lid containing MPA. Attach label LHMPA (18).

| µl | Volume aliquotted | HH:MM | Time aliquotted | HH:MM | Time in freezer | HH:MM | |----|-------------------|-------|-----------------|-------|-----------------|-------| | | | | | | | |

Wash red blood cells in monovettes LHN1, LHN2 and LHN3 using saline 3 times. After each wash, centrifuge for 10mins and then discard the supernatant. Place washed red blood cells in their original monovettes in the freezer.

| Time monovettes in freezer: | HH:MM | HH:MM | HH:MM | HH:MM | HH:MM | HH:MM | |-----------------------------|-------|-------|-------|-------|-------|-------|

Storage Freezer temperature: ————°C

Have you completed all relevant fields? Yes / No

Print name: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Signature: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Field lab name: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Please fax/ email both sides of this despatch form after sample processing to HNR

FAX: 01223 437546 EMAIL: ndns.fieldlab@mrc-hnr.cam.ac.uk

HNR will arrange for the collection of samples and these forms via courier National Diet and Nutrition Survey (NDNS) FIELD LAB DESPATCH NOTE – 7 to 15 YEARS

Nurse Section Participant details

Affix label FL1 (13) here Affix label FL2 (14) on reverse

Sex: Male / Female Fasted sample: Yes / No Sample collection date: DD / MM / YY Sample collection time: HH : MM 24 hr clock

Have you delivered all the items on the checklist to the field lab? Yes / No Time samples delivered to field lab: HH : MM 24 hr clock

Field Lab Section Date sample arrived: DD / MM / YY Time sample arrived: HH : MM 24 hr clock

| Blood Monovette Tubes | SEN1 | LHN1 | LHN2 | FN1 | |-----------------------|------|------|------|-----| | Sample received? | Yes / No | Yes / No | Yes / No | Yes / No | | Is tube full or partial? | Full / Partial | Full / Partial | Full / Partial | Full / Partial | | Is tube damaged? | Yes / No | Yes / No | Yes / No | Yes / No |

Centrifuge tubes for 20mins at 4°C and 2000g

| Time tubes placed in the centrifuge | HH : MM | HH : MM | HH : MM | HH : MM | |------------------------------------|---------|---------|---------|---------|

Did you use a refrigerated centrifuge? Yes / No

If NO, explain here what you did to keep samples cool:

______________________________________________________________________

Annex 50_Nurse visit consent booklet_office_v10\_ NDNS RP Y6-9

For use from 01/07/16 Describe here any problems or deviations from protocol:

| Blood Monovette Tubes | SEN1 | LHN1 | LHN2 | FN1 | |-----------------------|------|------|------|-----| | Is sample normal? | Yes / No | Yes / No | Yes / No | Yes / No | | If NO, describe e.g. haemolysed, cloudy, clotted, not clotted (SEN1 only) | | | | |

**Aliquot ALL plasma/serum unless otherwise stated; do not contaminate with cells**

| Microtube size | 5ml | 5ml | 5ml | 2ml | |----------------|-----|-----|-----|-----| | Attach label | SERUM | LIHEP1 | LIHEP2 | FLOX | | Time aliquotted: | HH : MM | HH : MM | HH : MM | HH : MM |

**Take EXACTLY 300µl plasma from LIHEP1. Use 2ml microtube with green lid containing MPA. Attach label LHMPA (18).**

| Volume aliquotted | HH : MM | Time aliquotted | HH : MM | Time in freezer | HH : MM | |-------------------|---------|-----------------|---------|-----------------|---------|

**Time aliquots in freezer:**

| HH : MM | HH : MM | HH : MM | HH : MM | |---------|---------|---------|---------|

Wash red blood cells in monovettes LHN1 and LHN2 using saline 3 times. After each wash, centrifuge for 10mins and then discard the supernatant. Place washed red blood cells in their original monovettes in the freezer.

| Time monovettes in freezer: | HH : MM | HH : MM | |-----------------------------|---------|---------|

Storage Freezer temperature: \_\_\_\_\_\_\_ °C

Have you completed all relevant fields? Yes / No

Print name: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Signature: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Field lab name: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Please fax/ email both sides of this despatch form after sample processing to HNR

FAX: 01223 437546 EMAIL: ndns.fieldlab@mrc-hnr.cam.ac.uk HNR will arrange for the collection of samples and these forms via courier National Diet and Nutrition Survey (NDNS) FIELD LAB DESPATCH NOTE – 1.5 to 6 YEARS

Nurse Section Participant details

Sex: Male / Female Fasted sample: Yes / No Sample collection date: DD / MM / YY Sample collection time: HH : MM 24 hr clock

Have you delivered all the items on the checklist to the field lab? Yes / No Time samples delivered to field lab: HH : MM 24 hr clock

Field Lab Section Date sample arrived: DD / MM / YY Time sample arrived: HH : MM 24 hr clock

| Blood Monovette Tubes | | |-----------------------|--| | SEN1 | LHN1 | | Sample received? | Yes / No | Yes / No | | Is tube full or partial? | Full / Partial | Full / Partial | | Is tube damaged? | Yes / No | Yes / No |

Centrifuge tubes for 20mins at 4°C and 2000g

Time tubes placed in the centrifuge: HH : MM

Did you use a refrigerated centrifuge? Yes / No

If NO, explain here what you did to keep samples cool:

______________________________________________________________________

Annex 50_Nurse visit consent booklet_office_v10\_ NDNS RP Y6-9 Describe here any problems or deviations from protocol:

| Blood Monovette Tubes | | |-----------------------|--| | SEN1 | LHN1 | | Is sample normal? | Yes / No | Yes / No | | If NO, describe e.g. haemolysed, cloudy, clotted, not clotted (SEN1 only) | |

**Aliquot ALL plasma/serum unless otherwise stated; do not contaminate with cells**

| Microtube size | 5ml | 5ml | |----------------|-----|-----| | Attach label | SERUM | LIHEP1 | | Time aliquotted: | HH : MM | HH : MM |

**Take EXACTLY 300µl plasma from LIHEP1. Use 2ml microtube with green lid containing MPA. Attach label LHMPA (18).**

| µl | Volume aliquotted | |----|-------------------| | HH : MM | Time aliquotted | | HH : MM | Time in freezer |

| Time aliquots in freezer: | HH : MM | |---------------------------|---------|

Wash red blood cells in monovette LHN1 using saline 3 times. After each wash, centrifuge for 10mins and then discard the supernatant. Place washed red blood cells in their original monovette in the freezer.

| Time monovette in freezer: | HH : MM | |-----------------------------|---------|

Storage Freezer temperature: ————°C

Have you completed all relevant fields? Yes / No

Print name:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Signature:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Field lab name:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Please fax/ email both sides of this despatch form after sample processing to HNR

FAX: 01223 437546 EMAIL: ndns.fieldlab@mrc-hnr.cam.ac.uk

HNR will arrange for the collection of samples and these forms via courier

1. **Participant details**

   Please affix OFFDESP (2) label here

2. **Age group:**

   | 16+ | EDTA | Serum | Li Hep TM | Li Hep TM | |-----|------|-------|-----------|-----------| | | | | | | | | | | | | | | | | | |

   | 7-15 | EDTA | Serum | Li Hep TM | Li Hep | |------|------|-------|-----------|-------| | | | | | | | | | | | | | | | | | |

   | 18mths – 6 yrs | EDTA | Serum | Li Hep | |----------------|------|-------|-------| | | | | | | | | | | | | | | |

3. **Date blood sample taken:**

   DAY: [ ] MONTH: [ ] YEAR: [ ]

4. **Time blood sample taken:**

   TIME: [ ]

5. **Date blood despatched to Addenbrookes:**

   DAY: [ ] MONTH: [ ] YEAR: [ ]

6. **Did you experience any problems in taking the Venepuncture? If yes, please record these below and state what action you took. (PROMPTED FROM CAPI)**